BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    NASAL OXYGEN CANNULA OXYGEN MASK

    K Number: K812208 · Decision Aug 25, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    269
    Registration Numbers
    269
    Same Product Code
    54
    Applicant Total
    1
    Review Days
    21

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    Basic Information

    Device Name
    NASAL OXYGEN CANNULA OXYGEN MASK
    K Number
    K812208
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5580
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Kamei Intl. Corp.
    Date Received
    August 4, 1981
    Decision Date
    August 25, 1981
    Product Code
    BYG
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    BYG Mask, Oxygen

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